Status:
COMPLETED
Omega-3 Fatty Acids and/or Multi-domain Intervention in the Prevention of Age-related Cognitive Decline
Lead Sponsor:
University Hospital, Toulouse
Conditions:
Frail Elderly Subjects
Eligibility:
All Genders
70+ years
Phase:
NA
Brief Summary
Epidemiological and fundamental research carried out in recent years has highlighted the role played by omega-3 fatty acids in the process of cognitive decline that accompanies advancing age and Alzhe...
Detailed Description
This is a multi-centre , randomised, placebo-controlled study in parallel groups in 1680 frail elderly subjects over the age of 70 years, living at home, monitored for a period of 3 years. The subject...
Eligibility Criteria
Inclusion
- subjects of both sex, aged of 70 years or over,
- subjects with at least one of the following frailty criteria: a subjective memory complaint, expressed to their attending physician, an inability to perform one of instrumental activities of daily living, a slow walking with a speed ≤ 0.77 m/s, i.e 5 seconds to walk 4 meters.
- subjects with an MMSE score of greater than or equal to 24,
- subjects capable of understanding the protocol, complying with its requirements and attending the study visits,
- subjects with sufficient availability to take part in the multi-domain intervention programme,
- subjects who, in the opinion of the investigator, are liable to comply with the treatment during the study;
- subjects capable of giving their written informed consent
- Covered by a health insurance system
Exclusion
- Criteria related to diseases:
- known presence of dementia or Alzheimer's disease (DSM IV criteria),
- deterioration in global cognitive function (MMSE \< 24),
- dependency for basic activities of daily living (ADL\<6),
- presence of serious diseases, which could be life-threatening in the short term,
- history or presence of any disease that could compromise the subject's participation in the multi-domain intervention sessions,
- Criteria related to treatments:
- o taking of supplements containing omega-3 (apart from food) within the past 6 months and/or taking omega-3 at inclusion.
- Criteria related to subjects:
- visual or hearing impairments incompatible with performance and/or interpretation of the neuropsychological tests,
- history or presence of any previous pathologies that could, in the opinion of the investigator, interfere with the results of the study or expose the subject to an additional risk,
- subjects deprived of their freedom by administrative or judicial decision, or under guardianship or admitted to a healthcare or social institution,
- participation in another clinical study in the previous month or participation scheduled during the study.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
1680 Patients enrolled
Trial Details
Trial ID
NCT00672685
Start Date
May 1 2008
End Date
April 1 2014
Last Update
April 17 2015
Active Locations (13)
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1
University Hospital Bordeaux
Bordeaux, France, 33000
2
Regional Hospital
Castres, France, 81108
3
University Hospital of Dijon
Dijon, France, 21033
4
Regional Hospital
Foix, France, 09017